Current Environment:


It is difficult to assess pain and agitation in the NICU population because for a multitude of reasons including the pre-verbal nature of the patient population, the atypical pain response of premature infants, and the use of muscle relaxing medications that exclude motor response in pain assessments. Current assessment tools are based on physical exam and vital signs. The investigators propose to study the role of EEG and palmar conductance (PD) as additional tools in the assessment of pain and agitation


Pain, Postoperative

Recruitment Status


Detailed Description

This is a prospective, non-interventional study designed to assess noxious-specific neurophysiologic responses and clinical signs following procedural pain in infants requiring hospitalization in the neonatal intensive care unit (NICU) following elective surgery. The main goal of the study is to develop a method that reliably quantifies the level of pain induced from clinically-required noxious procedures to infants hospitalized in the NICU. This method will use measures of neurophysiological, autonomic, and behavioral responses to non-noxious and clinically-required noxious stimuli in order to guide the pharmacological treatment of NICU patients with analgesic agents, sedatives and/or muscle relaxants. The investigators hypothesize that resting state activity and physiological responses to noxious and non-noxious stimuli provide a more reliable assessment of the level of pain of infants hospitalized in the NICU compared to behavioral-based pain scores.

Eligibility Criteria

Inclusion Criteria:

All patients will be admitted to the NICU, and having a post-menstrual age of >28 weeks. Participants will be divided into four groups according to the following criteria:

Group A

Plan for major surgery anticipated to cause pain and agitation (i.e. esophageal atresia treatment);
Patients who are anticipated to receive prolonged post-surgical neuromuscular blockade

Group B

Plan for major surgery anticipated to cause pain and agitation (i.e. bowel surgery);
Patients who are not anticipated to receive acute post-surgical neuromuscular blockade

Group C Plan for minor surgery anticipated to cause pain and agitation (i.e. hernia repair);

Group D No plan for surgery

Exclusion Criteria:

Confirmed or suspected clinical seizures
Metabolic abnormalities or inborn error of metabolism
Skin abrasions or wounds located at the site of research sensor placement i.e. scalp, which interfere with the application of electrodes


Intervention Type

Intervention Name


Waveguard (TM) EEG cap


Micro Movement Sensor


Pico Movement Sensor


QS Piezostimulator


tactileTM sensory evaluator



Min Age

1 Hour

Max Age

6 Months

Download Date

September 15, 2022

Principal Investigator

Laura Cornelissen PhD

Primary Contact Information

For more information on this trial, visit


For more information and to contact the study team:

Innovative Approaches to Assessment of Pain Control and Sedation in the NICU NCT03057782